Heart FailureNCT07722468
Heart Failure Self Care Education in Rwanda
A study testing HF Education in people with Heart Failure, run by Boston Medical Center at 1 site in Rwanda.
Trial summary
In Rwanda, patients with heart failure may have low health education about their condition. Heart failure care requires active patient involvement. Self-care of heart failure requires healthy lifestyle, attention to symptoms, proper action when new symptoms develop. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- HF Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteRwanda
- Study dates
- Jan 2027to Dec 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants living with heart failure followed at non-communicable disease clinics across three district hospitals (DHs) i- Butaro, Kirehe, and Rwinkwavu
- Able to provide informed consent; for minors, able to provide assent with parent or caregiver consent.
- Pediatric participants must be aged ≥10 years; consent will be obtained from a parent or caregiver, with age-appropriate assent from the child.
Who cannot join
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
In Rwanda, patients with heart failure may have low health education about their condition. Heart failure care requires active patient involvement. Self-care of heart failure requires healthy lifestyle, attention to symptoms, proper action when new symptoms develop. However, many patients may choose to stop taking medications when they are feeling well, or disregard new symptoms when they develop and delaying care until their condition is more severe. Educating patients in self-care for heart failure can be achieved by clinical staff with the support of patient handbooks or flip books. Self-care education materials have been developed by the research team in Haiti and have been adapted for Rwanda.
This study will use a cluster, stepped wedge design. Patients are already in clusters based on their health facility. The order of implementation will be randomized by the cluster. The primary outcome is heart failure knowledge assessed pre- and post-intervention through a structured survey.
- Conditions
- Heart Failure
- Being tested
- HF Education
- Keywords
- Heart failure education, Group education sessions, District hospital clinics, Rwanda
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HF EducationOther
The non-communicable disease clinic nurse educator will deliver the education. An illustrated flip book to guide the education. Participants will be given a simplified handout summarizing key educational objectives. These educational tools are translated in Kinyarwanda.
| Study group | Role | What they receive |
|---|---|---|
| Group-based HF Education | Experimental | A one-day group-based educational intervention about HF will be provided eligible participants, Receives: Other: HF Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-care of Heart Failure (HF)
This outcome will be assessed with the Self-care of Heart Failure Index (SCHFI). which has subcategories for behaviors, self-monitoring activities and symptom recognition, behaviors based on recognized symptoms, and confidence in behaviors. The SCHFI is a 38-question survey and each question has a 5-point Likert scale response(1= strongly disagree, 5= strongly agree). Total scores can range from 38-190, and higher scores are more favorable.
Measured: Baseline, 4 weeks, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study startJan 2027 (estimated)
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- A hybrid type 1 effectiveness-implementation design will be used to test the effect of an educational intervention on Self-Care of HF knowledge, HF clinical status and other clinical outcomes while observing and collecting implementation outcomes. Specifically, a cluster, stepped-wedge (non randomized) trial that will test the effect of an educational intervention will be conducted.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Inshuti Mu Buzima, Rwanda
- Responsible party
- Sponsor
- Investigators
- Gene F Kwan, MD MPH, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07722468
- Sponsor's protocol ID
- H-45872
- Status last verified
- Sep 2026
- First submitted
- 16 Jun 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No